Regulatory Focus™ > News Articles > Spotlight on Counterfeiting After Fake Avastin Found in US

Spotlight on Counterfeiting After Fake Avastin Found in US

Posted 17 February 2012 | By Alexander Gaffney, RAC 

Counterfeit copies of Avastin-an oncology drug with numerous indications-is casting a harsh spotlight on the safety of the pharmaceutical supply chain and causing experts to ask how it can be strengthened.

Perhaps the most prominent idea put forth by experts is a so-called 'track and trace' system for verifying pharmaceutical integrity. The US Food and Drug Administration (FDA) is expected to release a proposal for such a system within the coming year, notes the Associated Press.

The agency announced on 14 February that counterfeit copies of Roche Holding AG's drug Avastin (bevacizumab) had been found in the US, and that such copies lacked the active pharmaceutical ingredient (API) that makes the drug safe and effective.

The Wall Street Journal notes that injectable drugs such as Avastin are becoming "increasingly attractive to counterfeiters" due to their high price. Such counterfeiters are also increasingly using foreign distributors that are disguised to appear to be domestic distributors. The fake Avastin announced by FDA allegedly came from a foreign supplier calling itself "Montana Healthcare Solutions." The practice was selling the Avastin for hundreds of dollars less per dose than the other four approved US distributors of the drug were selling it for.

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